There might be a way to ensure women’s legal access to abortion isn’t entirely shut off, however, by focusing on federal authority for regulating all drugs. That authority includes medication abortion, a two-pill regimen that can be used during the first 10 weeks of a pregnancy, obtained through a telehealth visit and a prescription delivered in the mail.
The question is, can states block the use of abortion pills — even though they are fully approved by the US Food and Drug Administration? For a review of the legal landscape and the somewhat complex answer to that question, I spoke with Greer Donley, an assistant professor at the University of Pittsburgh School of Law, an expert on reproductive health care and the law, particularly abortion and contraception. Here is a lightly edited transcript of our discussion:
Lisa Jarvis: Given the pending Court decision, health and legal experts have come to view medication abortion as the next front in the battle over reproductive rights. Why is that?
Greer Donley: One thing that’s really important to realize about the pre-Roe and the post-Roe era is that the nature of abortion has radically changed. Before Roe, and really until about 2000, abortion was usually a procedure done in an office. But in 2000, the FDA approved a medical regimen, two drugs [mifepristone and misoprostol] that were able to end the pregnancy without any sort of a procedure. For a long time, FDA imposed pretty onerous regulations on [mifepristone]. But with the telehealth revolution that happened during Covid-19, FDA loosened its rules and allowed abortion by telehealth and abortion by mail. This has radically changed how many people are accessing abortion in this country. It is not uncommon for people in most states to access abortion without ever having to go to an abortion clinic, and without ever having to stand in the physical presence of a provider.
Historically, [states] were able to control and stop abortion by threatening to put doctors in jail or take away their medical license if they offered abortions. But what happens when a pregnant person no longer needs a doctor? State abortion bans are going to be somewhat ineffective at dealing with the many Americans who can access abortion without ever needing to go to a clinic.
LJ: A patchwork of rules currently exists around medication abortion, with 19 states already putting tougher restrictions on how mifepristone can be prescribed. If those states ban abortion entirely, what does that mean for access to medication abortion?
GD: People have been accessing medication abortion outside of the legal health-care system in this country since 2017. Aid Access is an international organization where pregnant people can meet with a doctor in Europe. And that doctor will call the prescription into an international pharmacy that will ship the drugs to their house. That’s often not legal according to state laws, but people are accessing abortion. And it will probably happen again in states that ban abortion entirely.
LJ: Are there specific things that the FDA can do now to ease access to medication abortion?
GD: Yes. One of the most frustrating pieces of rhetoric I’ve seen in the last week is that [President Joe] Biden can’t do anything to improve abortion access. That’s not true. One of the easiest things the Biden administration can do is to remove the mifepristone REMS [Risk Evaluation and Mitigation Strategies, a set of special prescribing rules] in its entirety. In December, the FDA removed one part, the in-person dispensing requirement. But other parts are still in effect. Probably the most important one is the certified provider requirement. This requirement forces doctors to opt into a system where they prescribe mifepristone. The only people who have opted into prescribing this drug are abortion providers, and this has really isolated abortion care outside of traditional health-care facilities. In a different world, a pregnant person could go in to their GP or their regular OB and say, “I’m pregnant, I don’t want to be.” That doctor could prescribe the medication, they could walk to CVS, pick up the prescription and have an abortion in their house.
These drugs are incredibly safe, incredibly well studied, very effective. There’s really no reason the FDA doesn’t allow that to occur. This would help blue states — which are going to have this huge influx of patients coming to them from the South and Midwest — scale up.
LJ: If Roe is overturned, many states will put in place even tougher laws around mifepristone. Already some have banned telehealth for abortion, and others hope to make it illegal to possess the drug. This is an FDA-approved drug. Are there precedents for states making their own rules around what drugs can and cannot be sold?
GD: One of the next legal battles will concern the concept of preemption. Historically, state abortion regulations were challenged through the Roe and Casey decisions. But if those are overturned, it forces us to think of novel arguments to poke holes in state abortion bans. One way to do that is the idea of preemption. Preemption essentially states that when there is a conflict between federal law and state law, federal law should trump it. A federal agency, the FDA, regulates medication abortion. Not only did it approve mifepristone and find the drug to be safe and effective for its intended use, but it is one of the most highly regulated drugs. States that are regulating the drug beyond that might be in conflict with the FDA.
Massachusetts decided to contradict the FDA and ban the opioid [Zohydro in 2014]. The [US District Court] of Massachusetts invalidated the state’s attempt, saying that action was preempted. This provides some persuasive authority to suggest that a state cannot ban an FDA-approved drug. The state laws that have been introduced to explicitly ban mifepristone or misoprostol are types of bans that could be challenged under that theory.
LJ: It sounds like if FDA got rid of the guardrails it has put on mifepristone, it would make it harder to make this preemption argument?
GD: Yes, it does. It’s a weird balance. The REMS is medically unnecessary, but the fact that it’s there certainly helps the preemption argument. The most ideal situation is for the FDA to maintain the REMS, but release the parts of it that are particularly onerous — the certified provider and the new certified pharmacy requirements — and keep the patient agreement form. Then, theoretically, it would expand access as extensively as it can while also supporting a preemption argument.
LJ: If Roe is overturned, are there specific cases you might expect to see that test these legal theories?
GD: It’s a matter of the right plaintiffs coming forward. GenBioPro, the manufacturer of the generic form of mifepristone, has already lodged a preemption challenge that was based on state in-person dispensing requirements. Pharmaceutical companies might be willing to take up this argument in a post-Roe world as well. But you could also imagine if there were good plaintiffs to bring this lawsuit, traditional [reproductive justice] organizations might also support those efforts.
LJ: Given that the FDA regulates all our drugs, could this outcome complicate health-care access beyond reproductive health?
GD: If a court were to say a state could ban certain drugs, the implications for the pharmaceutical industry are huge. Going to get a [new drug application] with the FDA is not some puny process, right? It takes hundreds of millions of dollars and sometimes decades of research. Companies endure those costs and time because they think it’s going to lead to a nationwide license to sell a product. If all of a sudden states can ban products, you can imagine companies being pretty upset. Now, they may not get involved in these lawsuits because they would say this is just related to abortion; it’s unlikely that other drugs will be politicized. But certainly with Zohydro, they were thinking that through.
LJ: Any last thoughts on the FDA and these challenges to medication abortion?
GD: Removing the REMS is something that people have been advocating for years. It’s based on science. That would be a pretty easy thing for the FDA to do. One step further would be for the FDA to try to involve itself in these preemption lawsuits that are certainly going to come down the pike, either as an amicus brief or something like that to say, “It is FDA’s view that these laws preempt state abortion bans.” That is a little bit more aggressive. We still think that is something that the Biden administration should consider pursuing.
That comes with some downsides. People might view the FDA as a political actor — at a time when the agency has come under criticism during Covid. Obviously, it’s good for the agency to be seen as a scientific, neutral arbiter. But agencies have to make decisions about things that are inherently political.
More from Bloomberg Opinion:
• Before Roe Falls, Congress Must Stand Up: Michael R. Bloomberg
• No Abortion Means Poor States Will Get Poorer: Allison Schrager
• Abortion Rights Falter as Democracy Slides: Clara F. Marques
This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.
Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, health care and the pharmaceutical industry. Previously, she was executive editor of Chemical & Engineering News.
More stories like this are available on bloomberg.com/opinion
